On January 19, 2016 Baxalta Incorporated (NYSE:BXLT), a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, reported that the European Commission has granted Marketing Authorization for use of ONCASPAR as a combination therapy in acute lymphoblastic leukaemia (ALL) in paediatric patients from birth to 18 years, and adult patients (Press release, Baxalta, JAN 19, 2016, View Source [SID:1234508806]). Schedule your 30 min Free 1stOncology Demo! With this approval, Baxalta is authorized to market ONCASPAR in the 28 member countries of the European Union (EU), as well as Iceland, Liechtenstein and Norway. The drug is already licensed to market in Argentina, Belarus, Germany, Kazakhstan, Poland, Russia, Ukraine and the United States.
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"ONCASPAR has been used as an integral component of the treatment regimen for paediatric and adult patients with ALL for many years, in Europe, and worldwide," said Prof. Dr. med. Martin Schrappe, director of the department of general paediatrics at the Schleswig-Holstein University Hospital in Kiel, Germany. "Today’s marketing authorization will ensure that more patients across the EU will benefit from access to ONCASPAR as part of a standard of care regimen."
With this authorization, ONCASPAR will provide an important treatment option for more European patients with this rapidly progressing cancer of the white blood cells responsible for up to 80 percent of childhood leukaemia cases – the most common type of childhood cancer. However, ALL is not only a childhood cancer but can also occur in adults. Adult ALL accounts for approximately 40 percent of the annual incidence.2
"For more than two decades, ONCASPAR has fulfilled a clear need for an effective and well-tolerated treatment for ALL patients worldwide. This European marketing authorization allows Baxalta to expand the use of ONCASPAR, improving treatment outcomes for all patients in the EU," said David Meek, executive vice president and president, Oncology, Baxalta. "This approval is important as we strive to make a difference in the lives of people living with cancer in all parts of the world."
About ONCASPAR (pegaspargase) in the EU
ONCASPAR is indicated as a component of antineoplastic combination therapy in acute lymphoblastic leukaemia (ALL) in paediatric patients from birth to 18 years, and adult patients.3
Contraindications3
Hypersensitivity to the active substance or to any of the excipients
Severe hepatic impairment (bilirubin > 3 times upper limit of normal [ULN]; transaminases > 10 times ULN)
History of serious thrombosis with prior L-asparaginase therapy
History of pancreatitis, including the related to previous asparaginase therapy
History of serious hemorrhagic events with prior L-asparaginase therapy
EU Important Safety Information
ONCASPAR is indicated as a component of antineoplastic combination therapy in acute lymphoblastic leukaemia (ALL) in paediatric patients from birth to 18 years, and adult patients.
ONCASPAR is contraindicated in patients with severe hepatic impairment (defined as bilirubin > 3 times upper limit of normal [ULN]; transaminases > 10 times ULN), a history of serious thrombosis with prior L asparaginase therapy, a history of pancreatitis, including the related to previous asparaginase therapy and those with a history of serious hemorrhagic events with prior L asparaginase therapy.
Anaphylaxis or serious allergic reactions can occur; therefore, patients should be observed for one hour after administration. Discontinue ONCASPAR in patients with serious allergic reactions. Patients with abdominal pain should be evaluated for evidence of pancreatitis. Discontinue ONCASPAR in patients with pancreatitis. ONCASPAR should also be discontinued in patients with serious thrombotic events.
Glucose intolerance, in some cases irreversible, can occur; serum glucose should be monitored. Coagulopathy and hepatotoxicity can occur; appropriate monitoring should be performed.
The most common adverse reactions with ONCASPAR (=2%) are allergic reactions (including anaphylaxis), hyperglycemia, pancreatitis, central nervous system (CNS) toxicity, thrombosis, coagulopathy, hyperbilirubinemia and elevated transaminases.
Hyperlipidemia (hypercholesterolemia and hypertriglyceridemia) has been reported in patients exposed to ONCASPAR.
Oncaspar may possess immunosuppressive activity. It is therefore possible that use of this medicinal product promotes infections in patients.
Combination therapy with Oncaspar can result in severe hepatic toxicity and central nervous system toxicity. Caution is required when Oncaspar is given in combination with other hepatotoxic substances, especially if there is preexisting hepatic impairment. In this case, patients should be monitored for liver impairment.
In the presence of symptoms of hyperammonemia (e.g. nausea, vomiting, lethargy, irritation), ammonia levels should be monitored closely.
Labeling may differ by country registration. Please refer to your country specific labeling for detailed information.
About Acute Lymphoblastic Leukaemia1
Acute lymphoblastic leukaemia (ALL) is a rare, fast-growing cancer of the white blood cells, and each year there are approximately 4,000-5,000 new cases in Europe and the United States, respectively. The disease is the most common childhood cancer and is responsible for more than 80 percent of childhood leukaemia cases. The five-year paediatric survival rate has climbed to more than 80 percent with modern therapies.